10 Things I Learned at the Consumers Union Safe Patient Summit - Part 1

Consumers Union invited me to speak at its Safe Patient Summit in Austin last week. The group of patient advocates, health care providers and reporters engaged in a fascinating discussion about how health care might become a more transparent industry and a less frightening and frustrating experience for those who are the victims of medical error or negligence. As the Office of Inspector General for the Department of Health and Human Services (HHS) showed in its report Tuesday, one in seven Medicare patients suffer an adverse event during hospital stays. The report also said that 44% of those events were preventable. The group in Austin focused its efforts on those preventable events. If errors can be prevented, then what can we do to speed that process up?

As Daniel R. Levinson, the HHS inspector general, wrote in USA Today, "Vigilance saves lives. Family members with hospitalized loved ones should educate themselves regarding medical treatment and expected outcomes and speak up when things go awry. Hospital staff should treat patients and their families as partners, welcoming family monitoring of patients as an additional safeguard against poor medical outcomes."

I learned a lot in my quick trip about how to be more vigilant. I was so energized by the sessions that I spent most of the flight back poring over my notes and jotting down ideas to share. Five ideas are below and five more will be coming next week:

1. Mark your calendars for 2013. It's not only when many of the big pieces of the federal health reform legislation go into effect, it's also when Sen. Chuck Grassley's bill, the Physician Payments Sunshine Act, will start requiring pharmaceutical firms to reveal which physicians they have on their payroll. Like the creation of the Drug Industry Document Archive, this promises to be a hugely valuable resource for health writers.

2. FDA 510(k) could spell a great story. Merrill Goozner, the health reporting icon who just took a job with The Fiscal Times, described how device makers can use the FDA's 510(k) Clearance process to skip clinical trials. The companies only have to show that the device is a slight improvement on an existing and proven treatment. For example, someone making a new bone screw for use in spinal surgeries might say that existing bone screws work great but theirs is made out of a stronger metal alloy.

As Goozner pointed out, "So these things are slightly improved and marketed as being improved but no one has any idea how they actually preform and whether they are doing anyone any good." As far as I know, this has not been investigated in any comprehensive way. If there are hundreds (thousands?) of devices on the market that have skipped the clinical trial process, wouldn't it be interesting to dig into a random sample and see if there was any way to tie themto patient outcomes?

3. PCORI is not NICE. It's too soon to tell, of course, whether the newly created Patient-Centered Outcomes Research Institute (PCORI) will be a nice thing for patients, but Goozner and others were skeptical. The main comparison they make is to the National Institute for Health and Clinical Excellence (NICE) in the UK. When NICE decides that one treatment is better than another, funding follows. If you have a treatment that has not been proven to be more effective butis more expensive, it will not be covered by the UK medical system.

PCORI, by contrast, is actually forbidden from requiring anybody to do anything with its findings. Medicare may take PCORI's work into consideration when deciding what to cover, but it cannot base its decision solely on PCORI. Also, the oversight board set up to decide where PCORI focuses its efforts could be prone to political manipulation.

4. Doctors who harm patients are just a symptom, not the illness. Gary Schwitzer, publisher of Health News Review, wasn't at the summit, but he likes to talk about how health writers focus too much on surrogate markers and don't make it clear to readers when a scientific study has not actually found evidence of a true reduction or increase in a disease. For example, stories often talk about cholesterol levels going up or down with a particular drug and then make the leap that heart disease and death rates will follow.

At the summit, speaker after speaker, including me, made the point that health writers and patient advocates can't focus all of their passions on the individual doctors who may have harmed them or their loved ones – the surrogate markers. They need to look at the hospitals where they operate, the boards that oversee those hospitals, the medical boards that oversee physician licensing, the state licensing boards that oversee hospital licensing, and, ultimately, the governors of the states where physician discipline or transparency are lacking.

5. Hundreds of tactics don't add up to a strategy. There was a lot of passion in the room at the summit, much of it borne out of personal pain. People had lost spouses, parents or children to medical errors. They had been deceived by their physicians. They had gone into a hospital with a minor problem and ended up with a hospital-acquired infection.

There were many good reasons to be mad, but as ProPublica's Charles Ornstein and other speakers pointed out, solving the errors that led to individual cases of deaths or injuries may not accomplish much in the end. Ornstein said that patient advocates should pick a handful of goals every year and work together on them to have a multiplier effect. Once they decide on their targets, they should spend $80 on a copier and start showing up at the appropriate agencies offering to make their own copies of as many records as they can get their hands on. "Once they see that you are willing to camp out in their offices, they are going help you because they know you are serious," Ornstein said.

Thanks to Lisa McGiffert, Suzanne Henry and Daniela Nuñez for organizing the summit and for asking me to participate.